Status:
COMPLETED
Solius UV Light Source in Improving Serum Levels of 25-hydroxyvitamin D
Lead Sponsor:
Boston University
Conditions:
Vitamin D Deficiency
Vitamin D Insufficiency
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
This is a feasibility interventional study seeking to determine the safety and efficacy of the Solius Photobiologic System in increasing the serum levels of 25(OH)D in a vitamin D deficient/insufficie...
Detailed Description
The investigators will conduct an interventional study to determine the changes in the changes in serum 25-hydroxyvitamin D levels between subjects who receive weekly exposures to Ultraviolet B Radiat...
Eligibility Criteria
Inclusion
- Age at least 22 years old
- Male or Female
- Skin Type I-VI
- Women of childbearing potential must be on birth control and not pregnant based on a negative pregnancy test at baseline.
- Ability and Willingness to give informed consent and comply to protocol requirements
- Serum total 25(OH)D \< 30 ng/mL
Exclusion
- Ongoing treatment with supplemental or pharmacological doses of vitamin D, vitamin D metabolites or analogues
- Pregnant
- History of underlying photosensitivity
- Use of medications that cause a photosensitivity reaction (including but not limited to): tetracycline, tretinoin, amiodarone, doxycycline, naproxen, diphenhydramine, methotrexate, and hydrochlorothiazide
- History of skin cancer
- Plan to received significant sun exposure below the 33rd parallel during study
- Used tanning or phototherapy devices within the last 30 days
- Vitamin D supplement use of more than 600 IUs daily.
- Systemic steroids use
- H1 antihistamine use in the last 7 days
- Diagnosed with light allergies (including but not limited to): actinic prurigo, polymorphous light eruption, or solar urticaria
- Diagnosed with light sensitivities (including but not limited to): protoporphyria, photodermatitis, xeroderma pigmentosum, lupus erythematosus, chronic actinic dermatitis, or UV-sensitive syndrome
Key Trial Info
Start Date :
August 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04865432
Start Date
August 24 2021
End Date
December 12 2021
Last Update
December 23 2022
Active Locations (1)
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1
General Clinical Research Unit (GCRU) BU School of Medicine
Boston, Massachusetts, United States, 02118